反相高效液相色谱法测定肠激安胶囊中芍药苷、盐酸小檗碱和盐酸巴马汀含量

目的: 建立肠激安胶囊中芍药苷、盐酸小檗碱和盐酸巴马汀的反相高效液相色谱(RP-HPLC)含量测定方法,进一步提升肠激安胶囊的质量标准. 方法: 采用Agilent ZORBAX SB-C₁₈色谱柱(4.6 mm×150 mm,5 μm),以乙腈-0.4%磷酸溶液为流动相进行梯度洗脱,流速0.8 mL·min^-1,检测波长230 nm,柱温30 ℃,测定肠激安制剂中芍药苷、盐酸小檗碱和盐酸巴马汀的含量. 结果: 芍药苷、盐酸小檗碱和盐酸巴马汀分离度良好,阴性溶液无干扰;芍药苷、盐酸小檗碱质量浓度在2.0~200.1 μg·mL^-1范围内线性关系良好,盐酸巴马汀质量浓度在2.0~200.2 μg·mL^-1 范围内线性关系良好;3批次肠激安胶囊中芍药苷的含量分 别为2.034 5、2.033 2、2.029 8 mg·g^-1,RSD为0.12%;盐酸小檗碱的含量分别为5.471 2、5.470 1、5.474 2 mg·g^-1,RSD为0.04%,盐酸巴马汀的含量分别为1.260 2、1.248 9、1.275 2 mg·g^-1,RSD为1.05%. 结论: 该方法可同步检测肠激安制剂中芍药苷、盐酸巴马汀和盐酸小檗碱的含量,精密度、稳定性和重复性良好;肠激安制剂中芍药苷、盐酸小檗碱和盐酸巴马汀的含量稳定可控.

Objective: To establish an RP-HPLC method for determination of paeoniflorin,berberine hydrochloride and palmatine hydrochloride in Changji'an capsules,so as to improve the quality standards of Changji'an capsules. Methods: RP-HPLC was used to determinate the contents of paeoniflorin,berberine hydrochloride and pal matine hydrochloride in Changji'an capsules.The Agilent ZORBAX SB-C₁₈ column(4.6 mm×150 mm,5 μm)was adopted with acetonitrile-0.4% phosphoric acid solution by gradient elution,the flow rate was 0.8 mL·min^-1, the detection wavelength was 230 nm and the column temperature was 30 ℃. Results: The separation was good for paeoniflorin,berberine hydrochloride and palmatine hydrochloride,the negative solution showed non-interference.The linear relationship was good within 2.0-200.1 μg·mL^-1 for paeoniflorin and berberine hydrochloride,2.0-200.2 μg·mL^-1 for palmatine hydrochloride.The contents in three batches of Changji'an capsules were 2.034 5 mg·g^-1,2.033 2 mg·g^-1,2.029 8 mg·g^-1 with RSD of 0.12% for paeoniflorin; 5.471 2 mg·g^-1,5.470 1 mg·g^-1,5.474 2 mg·g^-1 with RSD of 0.04% for berberine hydrochloride; 1.260 2 mg·g^-1,1.248 9 mg·g^-1,1.275 2 mg·g^-1 with RSD of 1.05% for palmatine hydrochloride. Conclusion: This RP-HPLC method could simultaneously determine the contents of paeoniflorin,berberine hydrochloride and palmatine hydrochloride in Changji'an capsules.The precision,stability and repeatability of this method were fine.The contents of paeoniflorin,berberine hydrochloride and palmatine hydrochloride in Changji'an capsules were stable and controllable.